Senior Safety Analyst

1 day ago

Manila, National Capital Region, Philippines beBeeCaseSpecialist Full time ₱6,000,000 - ₱8,000,000

We are seeking a highly skilled professional to join our team as a Case Specialist. The successful candidate will be responsible for managing and coordinating the activities of case handling, ensuring high-quality results.

Key Responsibilities:
  • Data entry of vigilance cases into relevant databases
  • Quality control of vigilance cases and associated documents
  • Medical review of vigilance cases in accordance with regulatory requirements
  • Follow-up on vigilance cases via phone and mail
  • Pre-analysis of complex cases prior to data entry
  • Identification of submission requirements for safety cases
  • Review and analysis of ICSRs from competent authorities databases
  • Performing reconciliations (partners, medical information, quality complaints)
  • Participation in operational implementation of new projects
  • Key contact for projects, with support from the team leader/activity manager/project manager
Requirements:
  • Pharmacist or Life Sciences degree with over 3 years of experience in PV
Ideal Candidate Profile:
  • Proven ability to work under deadlines
  • Excellent client communication skills
  • Minimum 3 years of experience working for service providers performing QC of cases
  • Strong pharmaceutical background, including understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety
  • In-depth knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment

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